Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents - 01/09/11
Abstract |
Background: The ascomycin derivative pimecrolimus (ASM 981) is a cell-selective cytokine inhibitor, specifically developed for the treatment of inflammatory skin diseases. Objective: When applied topically, pimecrolimus cream 1% has shown promise as a treatment for inflammatory skin conditions, including atopic dermatitis (AD) in children and adults, allergic contact dermatitis, and chronic contact irritant hand dermatitis in adults. Methods: In two independent 6-week, randomized, multicenter studies of identical design, the efficacy and safety of pimecrolimus cream 1% in children with predominantly moderate AD were compared with vehicle. Pooled data from a total of 403 patients were used in the analysis. The primary efficacy parameter was the Investigator's Global Assessment (IGA) score. Secondary parameters included Eczema Area and Severity Index (EASI) and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good, or complete. Results: Significant therapeutic benefits relative to vehicle were observed in the pimecrolimus-treated group at the first efficacy assessment, 8 days after initial application of the study medication (eg, relief of pruritus). At each subsequent postbaseline visit, pimecrolimus-treated patients showed significant improvement relative to controls in all efficacy measures. The medication was well tolerated. Conclusion: Pimecrolimus cream 1% appears to be a safe and effective alternative to currently used therapies for AD. (J Am Acad Dermatol 2002;46:495-504.)
Le texte complet de cet article est disponible en PDF.Abbreviations : AD, EASI, IGA, TBSA
Plan
 | Supported by a research grant from Novartis Pharmaceuticals Corporation, East Hanover, NJ. |
| Disclosure: Dr Eichenfield: Consultant to Novartis Pharmaceuticals, and Fujisawa Healthcare but does not own any equity stocks. Dr Lucky: Former consultant to Novartis Pharmaceuticals, Fujisawa Healthcare, and other pharmaceutical companies that manufacture corticosteroids for atopic dermatitis. Mr Boguniewicz: Has received clinical research trial grants from Novartis Pharmaceuticals and Fujisawa Healthcare. Dr Langley: QE2 Health Center received a research grant from Novartis Pharmaceuticals and Fujisawa Healthcare. R. Cherill, K. Marshall, C. Bush: Employees of Novartis Pharmaceuticals. Dr Graeber: Employee of Novartis Pharma AG. |
 | Reprint requests: Lawrence F. Eichenfield, MD, Pediatric and Adolescent Dermatology, Children's Hospital, San Diego, and University of California, San Diego School of Medicine, 3020 Children's Way, Mail Code 5092, San Diego, CA 92123. E-mail: leichenfield@UCSD.edu. |
Vol 46 - N° 4
P. 495-504 - avril 2002 Retour au numéro
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